Diabetes is a chronic disease that can be managed, but is not ordinarily cured by therapies and lifestyle changes. Patients typically experience a higher risk of disorders, such as atherosclerosis, peripheral artery disease, kidney disease, blindness, neuropathy, infections, and other disorders than non-diabetic patients especially at the extremities. This is especially the case for patients unable or unwilling to maintain their blood glucose levels at or close to normal ranges. Patients who control their blood glucose within or near the normal ranges by combinations of diet, appropriate medication, and exercise are found to experience reduced risk of many of the disorders that are associated with diabetes.
Foot infections are a particular disorder known to occur in diabetic patients, and tens of thousands of diabetic patients are subjected to toe and foot amputation annually because of foot infections, i.e., Diabetic Foot Ulcers (DFU's).
A newer therapy for type 1 and type 2 insulin dependent diabetics includes the use of insulin pumps and continuous glucose sensors. Insulin pumps use an infusion set having a needle that is percutaneously inserted into soft tissue. A portion of the needle remains outside of the insertion site, thus providing a pathway for skin flora to migrate along the inserted needle beneath the skin and proliferate, leading to infections around the inserted needle. Continuous glucose sensors are also inserted percutaneously into soft tissue, and provide readings of interstitial glucose levels. These devices can also lead to infections by the same circumstances described above for insulin pump needles.
In the course of placing an insertable or implantable device in a patient, contamination can occur, including infections and protein absorption at and around the inserted portion of the devices. Such contamination can occur rapidly, within a few days, and often interferes with the function of the device. Some devices may be coated to prevent such contamination. However, even with coated devices, exudate can seep from the insertion site and wet skin flora which can then diffuse back into the patient along the wetted device surface, thereby causing infection. The insertion site will also become wetted as a result of activities such as showers, and such wetting of the site may also lead to infections. Typically, when a needle or catheter is inserted, the area of insertion is cleaned with an antiseptic. However, such treatment is temporary, and the site may be palpated after swabbing, which can contaminate the site.